Prospective management process for medical benefit prescriptions

ABSTRACT

The present invention provides an interactive, electronic, knowledge-based ordering process for specialty/biotech pharmaceuticals (medically coded drugs) which results in less waste, improved procedural efficiencies, and greater cost savings than the current ordering systems. The knowledge-base of the system is based on the health plan&#39;s clinical policies as well as the status of the patient and their entitled benefits with the health plan, and it is applied in an interactive manner through a web-enabled system which provides a real-time, prospective examination and control over requests for authorization to dispense the medically coded drugs. The system also includes a feedback loop from the specialty pharmacies to provide information on the medicines that have actually been dispensed. The system also provides to the patient, educational material and adherence reminders to affect therapeutic outcomes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication No. 61/334,242 filed on May 13, 2010.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable.

APPENDIX

Not Applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and systems for managing theordering, approving, and filling of biotech/specialty drug prescriptionselectronically. In particular, this invention relates to methods andsystems in which healthcare providers submit prior authorizationrequests to health plans, obtain necessary approval per the healthplan's approval criteria, and submit medically-coded drug orders tospecialty pharmacies, all within a web-enabled platform.

2. Related Art

Pharmaceuticals come in oral, injected, inhaled, or infused versions.Generally speaking, drugs that are orally ingested or areself-administered are covered under the patients' pharmacy benefit withtheir respective health insurance plans. Pharmacy Benefit Managers (PBM)prospectively administer each prescription using a drug's National DrugCode (NDC). Every pharmaceutical has an assigned NDC code whichdescribes the package size (number of pills per package) and medicationdosages (i.e. mg/pill). While the vast majority of prescriptions aresupplied to patients under their pharmacy benefits (approximately 80%),medically coded drugs that require professional administration (i.e.infused, injected, or specific oral medications) are adjudicated as partof a patient's medical benefit portion of their health insurancecoverage.

These medically coded medications that fall under the medical benefittend to be biotech/specialty medications. The “specialty” term as usedherein may refer to a drug (“specialty drug” or “specialty medication”)or to a pharmacy (“specialty pharmacy”). Specialty drugs are usuallymade by a biotech manufacturing process, and specialty pharmacies storeand dispense these drugs in a manner appropriate for such biotechmedications. Generally, a biotech manufacturing process refers to anymanufacturing process for the production of medications that have a“biologic” or “protein-based” chemical make-up. These types ofmedications require injections or infusions rather than being orallyingested as well as special handling/refrigeration, and exhibittoxicities and side-effects which typically necessitate clinicaloversight during the course of the prescribed therapy. Drugs produced bybiotech manufacturing processes are used to treat a variety of diseases,including cancer.

These specialty drugs require professional administration and/orclinical oversight due to their particular characteristics. Therefore,these medically coded medications are billed manually on the same claimforms that are used for medical procedures, such as the HCFA-1500 orCMS-1500. Medical benefit procedural codes include J, S, and R codesthat are used to bill for a drug or other biological that isadministered to the patient by a physician (or a properly trained andsupervised physician assistant or nurse in the healthcare/medicalservice provider's office/practice). An example of a current claim formfor medical diagnoses, procedures and products, includingmedically-coded drugs, is shown in FIG. 12. The NDC code is rarelyincluded on the HCFA-1500 form. Currently, HCFA 1500 and CMS 1500 formsdo not capture a drug's NDC number to identify vial size, vial strength,or brand of medication dispensed. Manual auditing processes using theseforms have been used to capture NDC number dispensed. Accordingly, allof the current processes for using these forms are retrospective (i.e.,after the physician has performed the procedure and administered thedrug to the patient), and there are no automated prospective systems orprocesses in place for concurrently verifying patient's eligibility forthe drug, controlling the amount of drug that is used, steering to theoptimal setting of care, and for controlling duration of therapy beforethe procedure takes place.

The healthcare providers must continue to use the manual systems andprocesses for their billing of the medically-coded drugs because, priorto this invention, none of the current systems, including the electronicplatforms offered by the PBMs, have appreciated that an integratedsystem is necessary to automate the process. Specifically, an automatedsystem for ordering medically-coded drugs should have an integratedknowledge-base system that can prospectively evaluate the health plan'srequirements for prior authorizations of the drugs, preferably in anadaptive and interactive manner, as well as provide a feedback loopwhich tracks the corresponding drugs that the healthcare providersordered from the specialty pharmacies and ultimately administered to thepatients. The current PBM systems are not satisfactory for handlingmedically-coded drugs because the process for pharmacy-benefit drugs islinear, and the systems do not have a feedback loop that is integratedbetween the services provided by the healthcare provider and drugsdispensed by the pharmacy. Additionally, PBMs can only accept ordersfrom a pharmacy holding a licensed and unique pharmacy provider code.Medically-coded drugs originate in the doctor's office, which cannotaccess PBM systems.

In the typical situation in which a drug is covered under the patient'spharmacy benefit plan, a treating physician examines the patient,renders a diagnosis and prescribes a drug. The patient (orphysician/healthcare provider) chooses a pharmacy and upon receipt, thepharmacy dispenses the drug to the physician's practice or to thepatient for administration. The physician's medical office bills thehealth plan for the medical procedure, and any feedback loop on theservices between the medical office and the health plan, including theauthorization for the services and ultimate payment thereon, isperformed entirely apart from the pharmacy's dispensing of the drugs. Infact, the entire process between the physician and the health plan iscompletely unrelated to any interaction that may follow between thepatient's pharmacy and health plan. Whether or not the patient fills theprescription with the pharmacy has no bearing on whether the healthcareprovider will get paid because any authorization from the health planfor the medical services provided are wholly unrelated to the drugs thatare prescribed and then dispensed by a pharmacy as the pharmacy-benefitdrugs are covered under the pharmacy benefit plan. Therefore, thesystems that are used to manage the process between a medical office andits patients' health plans are devoid of any feedback from or integratedwith information from the patients' pharmacies.

Similarly, the subsequent process between the patient and the pharmacy,including authorizations from the health plan for coverage of thepharmacy-benefit drugs and subsequent payment, is wholly unrelated tothe authorization and payment for the medical services. Whether or not apharmacy is paid by a health plan for a drug it dispenses is whollyunrelated to any payments a medical office may receive for the medicaltests a physician performed on the patient in order to render adiagnosis and prescribe the appropriate drug. Accordingly, the currentsystems developed for PBM processes are focused on the interactionbetween the patient and the pharmacy and do not provide for muchintegration between the pharmacy and the healthcare provider.

Due to the lack of integration, functionality, and feedback in thecurrent systems that are used to manage pharmacy benefit plans, currentsystems are unable to automate the authorization and approval processfor medically-coded drugs. Additionally, the current PBM systems fail toincorporate a knowledge-base that should be used to speed the processingof requests for authorization approvals so that the requests can beperformed using adaptive and interactive processes, in real-time. Noneof the current systems are sufficiently integrated to permit theinteractive sharing of information between health plans, healthcareproviders and specialty pharmacies to permit the feedback necessary totrack medically-coded drugs that healthcare providers order fromspecialty pharmacies and ultimately administer to their patients intheir offices. Lastly, current systems cannot accept electronic requestsfrom the physician's practice, which is where an order for amedically-coded drug would originate.

While less than 20% of drug claims are billed as part of the medicalbenefit portion of a patient's health insurance, the medications in thiscategory are typically very expensive. In general, a monthly oralprescription averages $50 per prescription, while a monthlymedically-coded drug averages $1500 per prescription. Additionally,approximately 45%-50% of the drugs in the near-term pharmaceuticalpipeline are likely to be medically-coded drugs. Given these facts, andwithout the solutions offered by the process and system of the presentinvention, it is understandably why health plans have increasing concernover ways to control the costs of medically coded drugs. The concern isshared by all payers, including health insurance companies, governmentalhealth plans, and employers.

Medications billed to a medical benefit have National Drug Codes (NDC),but they are difficult to capture and quantify as the primary claimform, the HCFA-1500, cannot accept NDC-level coding. For example, ahealth plan may approve the use of the biotech drug REMICADE® under thecurrent manual processes. However, under the current process, the plandoes not know what dosage of REMICADE® is used or how often it isinfused when the approval is given. The REMICADE® drug is dispensed inliquid form for infusion based on patient weight and dose/kg needed forthat patient. Even though REMICADE® has an assigned NDC, the currentprocesses require that a J-code be identified to approve REMICADE® forthe treatment (instead of the NDC) because a health plan will not knowwhat dose of the drug is dispensed until after the specialty pharmacyhas provided the drug to the patient and/or physician. In general,health plans do not know what package size or dosage of medication isrequested or dispensed when a medication is billed to the medicalbenefit. This creates difficulty for payers to implement appropriateutilization management tools to control wastage, inappropriateutilization, and avoidable costs associated with medications dispensedand administered under a patient's medical benefit.

Operationally, health plans lack prospective controls to manage costsassociated with medically coded drugs billed as procedural J, R, or Scodes. As procedural codes they do not identify drug utilization at theNDC level. Even after an authorization is approved for a medical drugregimen, the cost for that transaction can vary greatly and will notbecome evident until the claim is submitted. As claims are typicallysubmitted 45-60 days after the date of service, payers can do verylittle to ensure optimal utilization and cost. Therefore, there is noprospective cost containment on the medically-coded drugs, only aretrospective evaluation based on a formal audit. Instead, what is trulyneeded is a prospective electronic authorization system which canaccount for the eligibility status of the patient and to adaptivelyguide a user to enter patient specific criteria, health plan specificcriteria, drug specific criteria, site of drug administration, andselect a pharmacy to dispense the medically coded drug. Other needs ofthe health plan are listed below.

As used herein, health plan generally refers to any entity that owns the“risk” for the medical care provided to its members. The health planterm can be used synonymously with “payer” or “health insurer”. HealthPlans typically require an approval process for procedures andmedications deemed to be high-cost or otherwise having the potential tobe mismanaged. Biotech/specialty drugs usually require priorauthorization, and when such a procedure or medication is required, thephysician or other healthcare service provider contacts the Health Planvia telephone or fax to obtain an approval. Using traditional systemsthat are currently in place, an approval typically takes 24-72 hours toobtain, and requires the transmittal of clinical and financialinformation. As it will become apparent from the description of theinvention provided herein, the inventive system reduces this approvaltime period from days to minutes. Once approved, the prescription andapproval are submitted to a pharmacy for dispensation, and the deliveryof the medication is coordinated with the physician and/or the patientfor injection/infusion.

A Pharmacy Benefit Manager (PBM) is a service provider that uses acomputer database to manage the utilization of common prescriptiondrugs. Requests for common drugs originate at the retail pharmacy, andthe PBM electronically verifies the patient's insurance coverage for thedrug, and imposes a tiered out-of-pocket cost structure based on thedrug that is ordered. PBMs also reimburse the pharmacy for the drugsthat are dispensed using a NCPDP claim form. The vast majority of PBMtransactions, including reimbursements, are conducted electronically.

Every pharmaceutical approved for sale in the USA has a specificNational Drug Code (NDC). The NDCs are typically 11 digits long, anddefine drug, manufacturer, vial size, and strength. PBM transactions usethe NDC for drug management and reimbursement. However, for the reasonsprovided above, medically coded drugs do not follow typical PBMadjudication because they require professional oversight, and requestsfor these drugs originate in a medical practice or clinic. The medicallycoded drugs are those medications that are often infused or injectedthat are paid from a patient's medical benefit portion of their healthinsurance coverage. As also explained above, the HCFA 1500/CMS 1500forms are typically used by healthcare/medical service providers to billclaims to Health Plans for procedures and/or medications. Biotechmedications are typically billed using these forms to charge a blendedrate for the drug and the infusion/injection procedure. HCFA-1500 formsdo not have the ability to capture the NDC for the drug that isadministered, nor can these forms be accepted by a PBM. The medicalbenefit procedural codes (J, S, R-Codes) are the procedural codes usedon the HCFA-1500 claim forms by healthcare/medical service providers togarner reimbursements for administering biotech/specialty medications.J-codes are blended codes, including the cost of the drug and the costto administer the drug.

For the reasons described above, the present systems and processes thatare currently in place for medically coded drugs need to be improved forhealthcare service providers, health plans and pharmaceuticalmanufacturers.

The needs of the health plan stakeholders are described above and arealso summarized in the Health Plan Needs table below.

Health Plan Needs

Electronic Platform to:

-   -   Verify Member Eligibility    -   Create and Transmit accurate Prescriptions and Supportive Data    -   Collect data at NDC Level of the Drug, even medically-coded        drugs    -   Speed Authorizations to the Physician and Dispensing Pharmacy

Prospective Process for:

-   -   Imposing Appropriate-Use Criteria and Clinical Edits    -   Imposing Preferred Drugs and Preferred Regimen    -   Directing Orders to Contracted/Credentialed Specialty Pharmacies    -   Steerage of the infusion to the Preferred Site of Care

Reporting Suite:

-   -   Provide NDC-to-J-Code Crosswalk reports to obtain Rebates    -   Reports to Affect Pharmacy & Therapeutic (P&T) Decisions

Clinical Review:

-   -   Manage the complications of Poly-Pharmacy    -   Manage Side-Effects and Toxicities    -   Manage Adherence and Compliance    -   Manage Dosing and Duration of therapy    -   Provide Care Alerts to manage Patient Safety

More Efficient Prior Authorization Workflow:

-   -   Reduce Prior Authorization Time for Physicians and Pharmacies    -   Reduce Payer Resources needed for Prior Authorization Process    -   Reduce Physician Resources needed for Prior Authorization        process

Pharmaceutical Manufacturers also have unmet needs associated withspecialty pharmaceuticals. From a manufacturer perspective, there is nocurrent way to track medically coded drugs for market share analysis,sales incentive compensation, forecasting, or budgeting of resources.Accordingly, the needs of pharmaceutical manufacturer stakeholders aresummarized in the Pharmaceutical Manufacturer Needs table below.

Pharmaceutical Manufacturer Needs

NDC level data for market share and sales analysis:

-   -   For specific drug, vial size, and strength    -   For diagnosis class    -   By geography

Lastly, the specialty pharmacy ultimately dispensing the medication alsohas unmet needs within the current process. Primarily, the pharmacy uponreceipt of a prescription, must allocate tremendous resourcing to verifyeligibility and obtain an authorization. Any error during this manualprocess will cause the claim for the service to be rejected. Given thecost of biotech medications, a rejected claim imposes hardship on apharmacy. The needs of specialty pharmacy stakeholders are summarized inthe Specialty Pharmacy Needs table below.

Specialty Pharmacy Needs

-   -   Reduce costs to manually verify eligibility and obtain        authorization    -   Reduce write-offs due to unpaid claims    -   2-3 day turn-around to obtain authorization    -   Prospective guidance to optimally manage dosing and duration

What is needed for healthcare organizations, including healthcareproviders, health plans, pharmaceutical manufacturers and specialtypharmacies, is a system and process that prospectively controlsmedically coded drugs and replaces the inefficient, time-consumingmanual process that is currently used. With prospective controls inplace, a health plan can apply utilization management tools, includecare alerts, recommended dosing based on evidence-based medicine, andstreamline workflow processes for physicians, specialty pharmacies, andinternal health plan reviewers. Also, with the ability to assign anaccurate NDC to medically-coded drugs (J-code billed medications) dataanalytics can be improved to capture rebates from drug manufacturers.Rebates are retrospective payments made by manufacturers to pharmaciesand other drug purchasers based on the ability to affect the drug'smarket share. Payments are reconciled by the manufacturer using reportssupplied by the pharmacy or healthcare service provider quantifying theamount of drug that was used (as defined by the drug's NDC). For thereasons discussed above, the current systems available to healthcareorganizations fail to satisfy these needs. The current systems aresummarized below.

Most PBMs use computer platforms for managing pharmacy benefit plans,but these current platforms are unsatisfactory for medically-codeddrugs. Current PBM systems do not have a knowledge-base that canevaluate medically-coded drug orders relative to the health plan'smedical benefit policies. Without a knowledge-base, there would not beany link between a medically-coded drug and the indicated usage underthe health plan's policies nor would there be any information onrecommended amounts of the drug dosage for a particular patient whichcould be based on a number of factors, including the course of treatment(initiation or continuation), weight, sex, age and frequency of therapy.Also, the current PBM systems can only accept requests for therapy froma pharmacy with a unique identifier code, and not from a physician'spractice from which medically-coded drugs originate.

When it comes to health plan approval systems, the prior authorizationprograms currently used by health plans do not provide prospective,adaptive, interactive, automated controls that allow the health plans tomanage utilization and generate rebates. Instead, the current systemsare manual, with healthcare providers using forms on paper or electronicrepresentations that they submit to the health plan via facsimile ore-mail. Prior authorization forms have been adopted by many plans as aremedial solution to apply basic management tools to medically-codeddrugs, and an example is shown in FIGS. 13A and 13B. Using priorauthorization forms is a manual process requiring intensive work bymedical offices and health plans. The process associated with usingprior authorization forms is not streamlined; it is time consuming andcreates only a few very basic management controls which are mostlyretrospective in nature, where true costs are only known after themedication has been dispensed and administered. Implementing a processusing prior authorization forms also does not allow a health plan todetermine what NDC should be assigned to a medication dispensed andbilled to a patient's medical benefit. Using the current systemstypically takes days to process a request for authorization approval todispense medically-coded drugs and only provides limited managementcontrols. Instead, what is needed is a system using an adaptive processto request a prior authorization where a medical office can submit onlyrelevant information, interactively and in real-time, taking onlyminutes, not days, and which give prospective management controls tohealth plans.

Neither the current PBM systems for drugs covered on as part of apatient's pharmacy benefit nor the health plan systems for medicalprocedures are satisfactory for managing medically-coded drugs.Additionally, merely combining the features of currently known systemswould not result in an optimal solution to the issues discussed above.Even though there are systems that provide an interactive orderingprocess for pharmacy benefit drugs and there are knowledge-bases whichhelp prevent ordering too much medicine and check for adverse druginteractions for a particular patient, merely combining these featuresfails to result in an integrated system which provides the medicaloffice with the prior authorization approval in a timely manner orprovides the health plan with an interactive ordering and pharmacyfeedback loop that provides the necessary information for efficientlycollecting information to capture rebates on the medically-codedmedicines.

Accordingly, to solve the need by healthcare organizations, a new systemand process that prospectively controls medical benefit medications isneeded, not one which merely combines features from currently knownsystems.

SUMMARY OF THE INVENTION

The present invention solves the problems described above by providing aprospective, adaptive, interactive, and integrated knowledge-basedordering process for specialty/biotech pharmaceuticals (medically codeddrugs). The knowledge-base of the system is based on the health plan'sclinical policies, as well as the eligibility status and the patient'smedical benefit coverage with their health insurer. It is applied in anadaptive and interactive manner through a web-enabled softwareapplication system which provides a real-time, prospective examinationand control over requests for authorization to dispense the medicallycoded drugs. The system also includes a feedback loop from thepharmacies to provide information on the medicines that have actuallybeen dispensed. The present system results in a faster, more-efficientprocessing of authorization approval requests that is not possible withthe current authorization approval process and results in less waste andgreater cost savings that could not be realized by the current orderingsystems. And by integrating the approval authorization system with theordering in a unique way with the dispensing feedback system, thepresent system results not only in benefits that have not been realizedbefore and were impossible to achieve and are also unexpected whenconsidering each of the known systems in an individual manner or whenmerely combining the features of these known systems.

In one aspect of the present invention, it is a payer-centric systemthat offers prospective control over a health plan's specialty/biotechpharmacy costs. This system accommodates all medically-coded drugs,including those used to treat cancer, applying a health plan's clinicalpolicies and edits before a medication is dispensed by a specialtypharmacy, hospital infusion suite, or physicians' practice. This systemis automated and adaptive through a web-enabled system, creatingefficiencies associated with providing metrics required to create a“clean” and authorized prior authorization request. Once a request isapproved, it is transmitted to a pharmacy in the health plan's specialtypharmacy provider network with a unique identification number created bythe system or some other authorization code that is unique to thetransaction.

In another aspect of the invention, it functions as a medical pharmacybenefit manager that allows a health plan to proactively plan,intervene, and manage specialty/biotech pharmacy spending.Specialty/biotech pharmaceuticals are currently processed usingprocedural codes (i.e. J-codes) that were not easily handled by a healthplan for adjudication (payment and processing) because of theretrospective systems and processes that had been used prior to thecreation of this invention. Because medically-coded drugs have acomplicated payment process which did not fit in the PBM systems andrequired manual processing and retrospective analysis under the medicalbenefit plan, prior to the present invention, they had been poorlymanaged creating waste, inappropriate utilization, safety concerns, andinefficiency.

In another aspect of the invention, it streamlines the health plan'sauthorization approval process with an integrated electronic,knowledge-based processing system. It allows a health plan to createpreferred drug status and metrics, define length of therapy, collectrebates, and improve patient care through an automated system.Prospective controls allow payers to improve patient outcomes byintervening in a patient's care before a medically-coded drug isdispensed, avoiding harmful drug interactions and poly-pharmacyduplications. Because the invention uses an adaptive intake form thatguides users to enter only needed metrics, efficiencies also impact thephysician's practice where requests for authorizations originate. Thisadaptive process and knowledge-based system reduces transaction timesfor approval, and eases the inputting process with algorithms that areconsistent with known prescriptive logic.

Additional features, functionalities and benefits that the presentinvention provides to payers and healthcare providers are listed below.

Features, Functions & Benefits for Payers & Healthcare Providers

-   -   Providers have an electronic authorization system that quickly        approves medically billed drugs through an interactive and        integrated, knowledge-based system.    -   Payers have prospective controls to improve patient outcomes,        reduce drug interactions, manage poly-pharmacy issues, eliminate        waste, and reduce inappropriate medication utilization.    -   Pharmacies will receive a “clean” referral that has validated        patient eligibility and conformance to the health plan's        clinical policies.    -   Health plans can enforce optimal drug dosages for prescribed        medications based on patient needs, body weight, lab values, and        diagnosis.    -   Health plans can manage length of therapy/duration to create        optimal medical outcomes for patients.    -   Health plans can access manufacturer rebates with NDC-level        utilization data.    -   Patients are provided with Drug Monographs, disease education,        and Compliance Tools to promote empowerment and quality of life.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the invention, are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a system block diagram of the present invention.

FIG. 2 is a flow chart of the system's process from the perspective of ahealthcare provider.

FIGS. 3 and 3A-3F are flow charts of the system's overall process andsub-processes.

FIGS. 4-11 are screen shots showing the operation of the system.

FIG. 12 is a prior art claim form for medical diagnoses, procedures andproducts.

FIG. 13 is a prior art prior authorization form for medically-codeddrugs.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

The present invention, identified by name as the RX Specialty HUB systemand process 10, is a software application system intended for direct useby healthcare/medical service providers, health plans, and pharmaciesand is preferably web-enabled. The system automates current manual priorauthorization processes, applies prospective management controls, andapplies NDC-level specificity to medications billed to a medical benefitand not processed through a standard PBM transaction. The system can beused as a stand alone tool or embedded into a physician's electronicmedical record software. The inventive system 10 is described below withprimary reference to the illustration in FIG. 1. Following thedescription of the system, the corresponding process and sub-processesof the inventive system 10 are described with reference to theillustrations in FIGS. 1 and 2. Each one of the modules and otherfeatures in the system 10 are then particularly described.

System Description

As particularly illustrated by the system block diagram in FIG. 1, thepresent invention is a medically-coded drug management system andcorresponding process 10 which has a database 12 with criteria 12′ for aplurality of medically-coded drugs 34 that are associated in thedatabase with a plurality of health plans 16 along with patientidentifiable information 28 that is associated with these health plans.The database also contains information on specialty pharmacies 36 withcapabilities to dispense the medically-coded drugs 34.

The system has a communication module 58 which allows the database 12 tobe in communication with healthcare providers 30 as well as the healthplans 16 and the specialty pharmacies 36. The communication moduleaccepts data feeds 42 that are in operative communication between thehealth plans and the database. Using the data feeds 42, a number ofhealth plans 16 communicate their health plan eligibility data 42′ forthe patients 32 in the respective health plans to the database 12. Thedata sets in the data feeds also contain the health plan criteria 42″which, as discussed in detail below, are used to determine whether ornot certain medically-coded drugs 34 fit within the health planguidelines for eligible patients. The communication module 58 alsoprovides for secured communication channels 58′ between the system 10and the health plans 16, the healthcare providers 30 and the specialtypharmacies 36.

The system 10 provides the healthcare providers 30 with a healthcareprovider interface 60 with a login interface 62, a data input and reviewinterface 64, and an authorization interface 66. A user 30′ who is anauthorized representative of a healthcare provider 30 gains access tothe system 10 through the login interface 62, submits input data 14′ toand accesses stored data 12′, 28, 34 in the database through the datainput and review interface 64 whereby the input data 14′ identifies apatient 32′ from the entire set of patients 32 using the patientidentifiable information 28, and by using an adaptive intake template 14that is linked to the database 12, the system 10 automaticallycorrelates the patient 32′ with a corresponding health plan 16′ andcompletes the remaining data fields 14″ in the adaptive intake 14 withinformation taken from the database based on the user input 14′. Forexample, the processor 44 may select corresponding patient information,health plan information and/or therapy options from the databaseaccording to the user input 14′. The authorized representative 30′ canalso select a medically-coded drug 34′ from the list of medically-codeddrugs 34 and can choose a specialty pharmacy 36′ from the availablespecialty pharmacies 36. When an identified patient 32′ is approved fora medically-coded drug 34′ as a part of a healthcare provider'streatment plan, the authorized representative 30′ receives an approvedauthorization code 18′ through the authorization interface 66.

To determine whether or not a patient 32′ is approved for amedically-coded drug 34′ that has been selected by the healthcareprovider's authorized representative 30′, the system uses a processor 44that communicates with the database 12 and the healthcare providerinterface 60. The processor 44 executes logic engines 44′ withinformation received form the database and the healthcare providerinterface to determine whether the identified patient is verified by thehealth plan eligibility data. When a patient is verified as being aneligible member of a health plan, the processor 44 produces anauthentication code 18 which is a unique transaction with a relationallink between the identified patient, the selected medically-coded drugand the authorized healthcare provider.

As discussed in more detail below, when a prior authorization request 38is submitted into the system 10, if the system's logic engine processing44′ cannot approve the request 38 automatically, the request status 38′may be pended 18″ while a medical management reviewer 76 evaluates thedetails of the prior authorization request 38. In the event that theprior authorization request 38 is approved 18′, the request status 38′changes from pended 18″ to approved 18′ and the overall transactionretains the same authentication code 18. Accordingly, in tracking atransaction through its entire life cycle using the present invention,the system 10 preferably uses an authentication code 18 in combinationwith an approved status 18′ as the transaction's authorization code 18′,and the system would have used the same authentication code 18 incombination with a pended status 18″ while the authorization request 38had been pended. It will be appreciated that the present invention couldalso use an authentication code that has alpha-numeric variations forthe pended status and the approved status, such as a suffix-p and asuffix-a respectively used in combination with the authentication code.

Once the transaction is authorized, the healthcare provider'srepresentative 30′ can use the system 10 to generate a referral form 40and select a specialty pharmacy 36′ for medication fulfillment, i.e.,dispensed medically-coded drugs 26. The healthcare provider may also oralternatively send an electronic prescription 78 directly to a chosenspecialty pharmacy 36′. Whichever method the healthcare provider decidesto use, the fulfillment continues to be identified and tracked withinthe system 10 as a part of the same overall transaction with the uniqueauthentication number 18 that was assigned to the transaction when theauthorization request was initially submitted.

The system 10 can receive a pharmacy dispensing report 20 through thesystem 10 from the chosen specialty pharmacy 36′. As discussed above,the pharmacy dispensing report 20 is associated with the authorizationcode 18′ and provides a pharmacy confirmation 20′ that the selectedmedically-coded drug 34′ was dispensed 26 to the authorized healthcareprovider 30′. As discussed below with respect to the J-Code/NDCcross-walk process 44″, the pharmacy confirmation 20′ includes a dosingdetail 50 at the NDC level. To complete the transaction, the systemreceives a medical claims report 22 from the authorized healthcareprovider 30′. As with the pharmacy dispensing report and all otheraspects of the overall transaction, the medical claims report 22 isassociated with the same authorization code 18′ and provides a medicalconfirmation 22′ that the selected medically-coded drug 34′ wasadministered to the particularly identified patient 32′. Once thefeedback is received from healthcare provider that the medically-codeddrug has been administered and the transaction is completed, theprocessor 44 calculates utilization data 24 corresponding to thepharmacy dispensing report and the medical claims report and updates theutilization data in the database.

In the preferred embodiment, the healthcare provider interface 60 isimplemented in a computer network 80, which may include any computerhaving a display screen, particularly including smart phones. It willalso be appreciated that the healthcare provider interface could beimplemented in a telephony network 82. In the preferred computer systemconfiguration, the login interface 62 is a web-enabled login screen 62′whereas in the telephonic arrangement, the login interface 62 can beimplemented using a telephonic keypad-entry login prompt 62″. Similarly,the data input and review interface 64 can be a web-enabled data screen64′ or a telephonic keypad-entry data prompt 64″a with a telephonicheadset data report 64″b, and the authorization interface 66 can be aweb-enabled authorization screen 66′ and a telephonic headsetauthorization report 66″. Accordingly, the secured communication channel58′ can be a web-enabled communication link, a telephonic communicationlink or any other type of electronic communication system, includingsatellite, WiFi or cable.

When the system 10 is implemented in a computer network 80, theprocessor 44 and the web-enabled data screen 64′ produces the adaptiveintake form 14. Similarly, when the system is implemented in a telephonynetwork 82, the processor 44 and the telephonic keypad-entry data prompt64″a and the information provided orally in the telephonic headset datareport 64″b is stored in the database 12 as the adaptive intake form 14.Regardless of the particular implementation of the system, computernetwork or telephony network, the adaptive intake form 14 is based onpatient specific metrics 32 and drug specific criteria 34 that theprocessor 44 uses to retrieve information from the database andautomatically complete the fields in the adaptive intake form.Accordingly, with the automatic completion of the adaptive intake form14, only the required inputs are prompted for the user to enter. Theadaptive intake form 14 is used to generate the referral form 40 thatcorresponds to the healthcare provider 30′ and the chosen specialtypharmacy 36′.

The system 10 provides the healthcare providers, health plans andspecialty pharmacies with dashboards 52 for tracking and managing themedically-coded drug transactions with which they are associated (i.e.,a healthcare provider dashboard 52 a, a health plan dashboard 52 b and aspecialty pharmacy dashboard 52 c). Accordingly, each one of thedashboards 52 has a respective docket 52′ that summarizes theinformation from the database 12. The docket 52′ in the healthcareprovider dashboard includes an authorization request docket having astatus report with a tracking of approved and pending authorizationrequests and an identification of pending tasks for completion. Thehealth plan dashboard's docket has a store of prior authorizationrequests, a viewer of the completed intake forms and clinical policiescorresponding with the particular health plan, a task tracker and amedical management review interface 74. The specialty pharmacy dashboardhas a report of approved requests tasked to the pharmacy fordispensation with a status of said request according to a need-by date.The system 10 also provides an efficient way for health plans andhealthcare providers to communicate patient information and educationalmaterials 56 with each other and with their respective insureds andpatients through a patient exchange 54.

Operation of System

The operation of the system, as described below, is particularlyillustrated in the corresponding illustrations from the perspective of ahealthcare provider user 30′ in FIG. 2 and from the perspective of thesystem 10 in FIGS. 3 and 3A-3F.

From the user's viewpoint 200, the healthcare provider chooses toprescribe a medically-coded drug (specialty drug) for a patient 205. Theuser 30′ logs into the system 10 and authenticates their user rights toaccess the system through the login interface 62 as an authorizedrepresentative of the healthcare provider 210. It will be appreciatedthat the system may be implemented as a centralized system for multiplehealth plans or it may be implemented by a number of individual healthplans.

The user accesses the database 12 through the healthcare providerinterface 60 and selects the desired medically-coded drug from the listof specialty drugs 215. The selection of the drug triggers a linkbetween adaptive intake 14 and the pharmacy benefit management database220. With the database link established 225, the user 30′ enters thepatient's name and date of birth 230. As discussed above, with the linkbetween the adaptive intake 14 and the database 12, the processor isable to automatically retrieve the other information for the identifiedpatient 32′ to complete the inputs 14′. As discussed in more detailbelow, the system's processor then determines whether the patient iseligible 235, 240. For an eligible patient, the user enters drugspecific inputs 245 and the system determines whether the therapycriteria 72 meets with the health plan policies 250, 255. When thecriteria is approved, the user confirms the selection of a specialtypharmacy 260 and the authorization code is sent to the selectedspecialty pharmacy for dispensing the medically-coded drug 265.

The automation provided by the system 10 makes the entire authorizationprocess much more efficient and timely so that the authorization code18′ is typically received within ten (10) minutes after entering theauthorization request. The authorization code can be received inreal-time, nearly instantaneously after the authorization request isentered while the user remains logged in with authenticated user rightsand is accessing the healthcare provider interface.

In the event that the patient is not eligible, the healthcare provideris notified by the system 270. In the event that the drug criteria ispended, the case details are sent to the health plan's medicalmanagement reviewer for further investigation 275. As discussed above,the medical management reviewer may authorize or deny themedically-coded drug as covered or not covered by the patient's healthplan medical benefit, respectively. The medical manager reviewer mayalso require additional information from the healthcare provider inorder to make a determination on the transaction's prior authorizationrequest. Accordingly, the healthcare provider user may send supportingdocumentation (SD) 48 to demonstrate a justified use of themedically-coded drug with a particular patient that may have otherwisebeen outside said clinical policies in the health plan. In this way, thepending medical management decision allows for an exchange ofinformation between the healthcare provider and the health planregarding the recommended therapy and health plan policies for theparticular patient.

When the medically-coded drug is authorized, the healthcare provider (orpossibly the patient) receives the selected medically-coded drug fromthe chosen specialty pharmacy or the healthcare provider purchases themedically-coded drug. The healthcare provider administers the selectedmedically-coded drug to the patient. The specialty pharmacy orhealthcare provider submits the medical claims report 22 to the system10 which stores it within the database 12. As discussed above, themedical claims report is linked to the entire transaction through theauthorization code and adds a medical confirmation 22′ that the selectedmedically-coded drug 34′ was dispensed 26 administered to saididentified patient.

The process is repeated numerous times for many different types ofmedically-coded drugs and corresponding patients. After the process isrepeated for a period of time, the system sends a drug level report 46summarizing the volumes 46′ of the medically-coded drugs administered tothe patients. The report can also contain a cross-walk key 46″correlating the medically-coded drugs with corresponding prescriptiondrug codes.

The system's viewpoint of the process 300 is similar to the viewpoint ofthe healthcare provider user 30′ but with much greater detail of thebehind-the-scenes processing to make the system 10 function efficiently.Also, the system 10 provides additional functionality for the healthplan users, particularly including the medical management reviewers, andfor the specialty pharmacy users which is not readily apparent from thehealthcare provider user's perspective.

As described above, the database 12 periodically receives data feeds 42from the health plans 16. The data feeds include a patient eligibilityinformation data feed 42′, patient identifiable information associatedwith the respective health plans, and a clinical policy data feed 42″.The system 10 interactively receives an input 14′ from a healthcareprovider user 30′ through the healthcare provider interface 60 in whicha health plan is selected 14 a, a medically-coded drug is selected 14 b,and a particular patient is identified 14 c. The logic engines 44′ ofthe system's processor 44 checks the patient information with thepatient information and health plan information in the database todetermine the eligibility of the patient 305. When the patient iseligible, the system automatically correlates the patient 32′ with acorresponding health plan 16′ and completes the remaining data fields14″ in the adaptive intake 14 with information taken from the databasebased on the user input 310.

The physician enters the weight and/or body mass of the patient and thediagnosis code 70 (ICD-9) 315. The logic engines 44′ of the system'sprocessor 44 determine whether the patient meets the corresponding setof clinical policies in the patient's health plan 320. The intake formis adaptive based on the patient weight, body mass and diagnosis codesuch that diagnostic feeds auto-populate the inputs when they areavailable 325. The healthcare provider user 30′ enters the remainingpatient clinical values and site of care 30″ needs 330. The system 10then determines whether the patient's clinical status and site of carerequirements meet with other sets of clinical policies in the patient'shealth plan 335. The intake form adapts based on the health plandispensing criteria and the drug dispensing options 340. The healthcareprovider user can use the healthcare provider interface 60 and chooseeither to purchase the medically-coded drug or use a specialty pharmacy345. The system again determines whether the chosen specialty pharmacymeets with a set of acceptable dispensing options in the health plan350. In the event that the healthcare provider would prefer to purchasethe medically-coded drug using a “Buy and Bill” model, the healthcareprovider is identified as the specialty pharmacy.

In the event that the patient is not eligible under their health plan,the system notifies the healthcare provider accordingly 355. In theevent that the patient's diagnosis, clinical status or site of care doesnot meet the health plan's corresponding set of clinical policies, or inthe event that the dispensing choice does not meet the correspondinghealth plan policy, the healthcare provider is notified of the pendingmedical management decision 360, and the pended prior authorizationrequest is docketed in the medical management reviewer dashboard 52 bfor viewing and entering a disposition.

When the patient diagnosis, clinical status and site of care meet thehealth plan's corresponding set of clinical policies and the dispensingchoice also meets the corresponding health plan policy, or when themedical management reviewer approves a pended prior authorizationrequest, the system provides an approved authorization code 18′ to theuser 365. As discussed above, the authorization code is a uniquetransaction identifier between the healthcare provider and theidentified patient for the selected medically-coded drug 34′ and therapycriteria 72 with the therapy criteria 72 being a duration period 72′and/or a dosage level 72″. Again, as described above, the adaptiveintake template form 14 is converted into a specialty pharmacy referralform 40 that the system 10 reports to the chosen specialty pharmacy 36′or the user sends to the chosen specialty pharmacy 36′ an e-prescriptionwith the authorization code 375.

After the chosen specialty pharmacy 36′ dispenses the medically-codeddrug 34, the specialty pharmacy 36′ sends and the system 10 receives apharmacy dispensing report 20. The dispensing report 20 is associatedwith said authorization code and provides a pharmacy confirmation thatthe selected medically-coded drug was dispensed to the healthcareprovider or the identified patient. As discussed below with respect tothe J-Code/NDC cross-walk process 44″, the pharmacy confirmation 20′includes a dosing detail 50 at the NDC level 380. The system alsoreceives a medical claims report from the health plan. The medicalclaims report is associated with the authorization code and provides amedical confirmation that the selected medically-coded drug wasadministered to the identified patient at the approved dosage. Thedatabase 12 is updated with utilization data corresponding to thepharmacy dispensing report and the medical claims report.

The system 10 accumulates the utilization data from a number of pharmacydispensing reports for a particular health plan and/or healthcareprovider. The system can prepare a utilization report from theaccumulated data which the health plan can use to reconcile rebateamounts.

The main features and functions are summarized in the list below andfurther supported by the corresponding illustrations, including blockdiagrams, flow charts and screen shots of the interactive interfaceenvisioned for the RX Specialty HUB system.

Web-Enabled Software Application—Features & Functions

-   -   Real time prior authorization approval using an adaptive process        specific to health plan policies, prescriber needs, and patient        eligibility    -   Formulary management of Specialty/Biotech Drugs leading to cost        management and rebate generation opportunities    -   Drug dosing calculators and other drug specific deterministic        criteria based on ICD-9 diagnosis, initiation or continuation of        therapy, FDA recommendations, and industry/evidence based        guidelines    -   MD, Health Plan Medical Management, and Specialty Pharmacy        “Dashboards” to view all submitted requests, the submission        date, and status of the request    -   Clinical Parameters (lab values and other clinical metrics),        Site of Care for Medication Administration, and Medication        Dispensing information captured and reported to the health plan    -   Care alerts reminding prescribers of precautions needed with        usage or administration of medication during the prescriptive        process    -   Monitoring capabilities to manage appropriate duration of        therapy and discontinuation of ineffective medication (includes        lab value monitoring, Quality of Life monitoring, and other        efficacy metrics)    -   E-prescribing capabilities (as technologies become entrenched)    -   Connectivity to, and automated transactions to find relevant        clinical data in a patient's electronic medical records (EMR)        when they become widely-established    -   Ability to transmit educational materials, Compliance Reminders,        and other supportive documents to a patient's email address    -   NDC assigned to all medically coded drugs dispensed as part of a        medical benefit    -   HIPPA compliant data management    -   Secure and redundant data storage    -   Drug-specific market share and utilization data    -   Complete patient information provided for Medical Management        Review when parameters are outside of clinical policies    -   E-mail notification of reminders to healthcare provider and        medical management reviewers about the status of the medication        request    -   Consistent referral forms generated for approved request and        provided in real time to Specialty Pharmacies for drug        fulfillment. Provided via facsimile, e-mail, or web-based        mediums    -   Reduced non-approved experimental use of medications    -   Uploading of support documentation (reports, lab values,        pictures, MRIs, etc.) as justification to use medications in        patients that are outside of clinical parameters

Referring again to the block diagram of the RX Specialty HUB system 10in FIG. 1, there are several key interfaces designed specifically foruse by the healthcare/medical service provider (physician, nurse andtheir medical office staff), the specialty pharmacy and pharmacist, andthe overseers and reviewers at the health plan. These interfaces areaccessible via a standard web browser after the user has beensuccessfully authenticated to the system.

RX Specialty HUB uses the database 12 at its core, serving a variety ofweb interfaces. It is constantly processing data inputs through itslogic engines, creating an adaptive intake form to guide the userthrough a branching logic process for adjudication of a medically codeddrug requiring prior authorization approval. The database contains manygroups of tables, each with parent to child relationships, main examplesof which are: Patient Eligibility Tables, Drug Tables, Pharmacy Tables,and Prescriber Tables. As it is a transactional framework, query-basedalgorithms are coded behind the web-based user interfaces. This allowsfor processing of healthcare provider or health plan Medical Managementinputs against pre-approval authorized rules from the health plan. Assome rules are dependent on prior inputs, the logic is branched and/ornested so as to provide a final adjudication on the authorizationrequest.

Data elements can be entered into the system by the healthcare providerand the health plan through prompted drop-down and radio buttonselections. Data elements required to substantiate approvals can also beauto-populated via access with patients' electronic medical records(EMR) and other clinical data inputs. The healthcare provider cangenerate a referral form and select a specialty pharmacy for medicationfulfillment and can also send an electronic prescription directly to achosen specialty pharmacy. As generally referred to herein, electronicmedical records (EMR) refer to any system or process where a patient'sentire health history and records are catalogued in a standardizedformat or manner and housed in a secure and searchable database toprovide real-time information for medical decision-making.

Patient data is either directly input into RX Specialty HUB by aprofessional healthcare provider (nurse, physician, physician assistant,or pharmacist), called into RX Specialty HUB telephonically and input bya RX Specialty HUB specialist or customer service representative, or viaelectronic access to the patient's Electronic Medical Record. Clinicalrules to process inputs are coded directly into the RX Specialty Hubapplication using application programming statements, generating anadaptive intake form which guides users to input only specific metrics.Eligibility Files are integrated directly into RX Specialty HUB througheither a direct connection with a health plan, through secure FTP orthrough another HIPAA compliant and secure data transfer process. Inputscaptured in the adaptive intake form are used to generate a referralform with the same unique authorization code 18 that is consistentlyused throughout the transaction in the Rx Specialty Hub system with thehealthcare provider, the health plan and the specialty pharmacy.Healthcare providers can send this referral form through the RxSpecialty Hub system to a selected specialty pharmacy for fulfillment ofthe medication; or healthcare providers can send an electronicprescription directly to a chosen specialty pharmacy. Electronicprescribing uses data transfer mechanisms required by e-prescribinglaws. Referral forms are generated within RX Specialty HUB and e-mailed,faxed, or uploaded to a secure website for use by specialty pharmaciesto fulfill medication requests. Physicians who are purchasing themedically-coded drugs are identified as specialty pharmacies. Specialtypharmacies use SMTP (email), FTP or an alternative secure electronictransfer process to provide feedback to the RX Specialty HUB system onall medication dispensed using RX Specialty HUB's referral process. Theclaims that are paid by the health plan are also electronicallysubmitted to RX Specialty HUB.

Several processes that comprise the RX Specialty HUB system aredescribed below, including the MD Workflow and Process Overview asillustrated in the flow chart of FIG. 2, the Overall Process asillustrated in FIG. 3 and particularly described with reference to theMD Interface, the Specialty Pharmacy Interface, the Data Feeds, theReal-Time Decision Interface, the Does Not Meet Criteria-Pending MedicalReview Notifications and Approval Notifications and the J-Code/NDCConversion Cross-Walk in the corresponding detail drawings.

MD Workflow and Process Overview

Once a physician diagnoses a condition and determines the appropriatemedication for treating the condition, the current healthcare provider'smedication-prescribing workflow requires them to determine specificallyif that patient is actively covered by the described health plan. Then,the physician must determine if the medication is dispensed through aretail or specialty pharmacy and if the medication should be billed tothe patient's medical benefit portion of their health insurance. Thephysician will then determine if a prior authorization is necessarybefore the medication can be filled. If a prior authorization is neededunder the current process, the healthcare provider must find a priorauthorization form (either a hard copy or an electronic version), andthen complete and submit the written form via facsimile or e-mail to thehealth plan. These drug specific forms may be located online or thehealthcare provider may need to request a prior authorization form fromthe health plan which may be faxed, e-mailed or mailed by a postalcarrier. Once a prior authorization form is located, the healthcareprovider must review the health plan's clinical policy to determine therequired information because there is little consistency in priorauthorization forms among health plans. The healthcare provider thenenters patient specific criteria on the prior authorization form used bya health plan.

Patient specific criteria entered on the form may include patientcontact information, birthday, age, weight, specific disease-relatedparameters and lab results. This information is usually gathered from apatient's file or found in an EMR and manually written onto the priorauthorization form. Once a prior authorization form is filled out,usually by a nurse or trained medical office staff, it is faxed back tothe health plan for review by their medical management department.

Upon receipt of the form by the health plan, each prior authorizationform is manually reviewed by a health plan's medical management staffreviewer and either approved or not-approved based on clinical policiesand other guidelines that the health plan has implemented and are withinthe policy of the particular patient's care that is the subject of thetransaction and is being evaluated. During the evaluation process, amedical management reviewer may contact the healthcare provider foradditional information not shown on the form. This back and forth datacollection process could take between 2-5 days, depending on theschedules and availability of the reviewer and the healthcare providerand the data being sought, including the availability of patient data.

The RX Specialty Hub system significantly improves a healthcareprovider's workflow to reduce the time associated with filling out aprior authorization form and the time required to determine if a priorauthorization has been approved. The time to approve a priorauthorization request (MD Auth) using the RX Specialty HUB is typicallyless than 5-10 minutes depending on the complexity of the medication.When a physician determines the appropriate medication, he/she logs intothe web-based system and chooses the appropriate medication. Eachmedication has specific clinical, site of care, and dispensing inputsbased on its ICD-9 diagnosis code and whether a patient is initiating orcontinuing therapy. In general, ICD-9 codes reflect the diagnosisdetermined by the physician upon patient examination, and are specificto a disease, and even to a certain stage of the disease. Because anadaptive intake form is used as part of the Real Time DecisionInterface, all required metrics are efficiently captured prospectively,before a prescription is dispensed and administered.

Because patients may have variations in coverage associated withmedications provided as part of their medical benefit, healthcareproviders are prompted to enter patient insurance information. Thisinformation is captured and validated by the RX Specialty Hub Real TimeDecision Interface with insurance eligibility information provided fromthe patient's health plan.

Healthcare providers are prompted to enter information as efficiently aspossible, leveraging drop down boxes and/or simple radio buttonswherever possible. An adaptive form is used for required inputs,minimizing the use of free text fields, which results in communicationbetween a healthcare provider and reviewer being more accurate andstreamlined than the traditional manual process, and input time isreduced. Also, the approval parameters are asked prospectively, whichmeans that no additional information needs to be collected if a patientis within clinical parameters for using the medication. If a patient iswithin clinical parameters, a prior authorization is automaticallyapproved and an RX Specialty HUB authorization number, or some otherunique transaction-specific authorization code, is automaticallygenerated when a healthcare provider clicks on the “final submit”button. Past and current referral requests are tracked and viewable bythe physician on the MD Dashboard, with referral status (approved orpended) clearly designated for each unique referral request andcorresponding authorization codes for approved referrals. The MDDashboard allows for a direct viewing of requests and management of theentire workflow.

If a patient does not meet all clinical policy parameters and otherguidelines required by a health plan, the prior authorization willremain pended for medical management review and the healthcare providerwill be notified that the request does not meet criteria. The healthcareprovider can either modify information requested so that it is withinclinical parameters, call medical management to discuss why a patientrequires unique care, or enter free text “notes” for the reviewer andwait for a reviewer to assess the case. The healthcare/medical serviceprovider can also upload supporting documentation (SD) to justify use ofa medication in a patient outside a health plan's clinical policies.Using a “browse-upload” function, electronic physician notes, labreports, MRI or X-Ray results can be attached and included as part ofthe authorization sent to the health plan's Medical Management reviewingdepartment.

Once a healthcare provider clicks the “final submit” button, a date/timestamp is applied to the transaction. Whether a patient's priorauthorization request is approved or pended, the RX Specialty Hub systemreduces the transaction time from 2-5 days to minutes. This improvesefficiency for the healthcare provider workflow, increases appropriateutilization of medication, and ultimately improves patient care.

The RX Specialty Hub system improves a health plan's medical managementreviewer workflow and lessens the time associated with each priorauthorization request. Little time is needed to re-assess these requestsbecause prior authorization requests that meet clinical policy areautomatically approved. By using the Health Plan Interface, medicalmanagement reviewers have much more consistent and complete informationto make quick decisions requiring few additional interactions withhealthcare providers because the prior authorization requests that donot meet the clinical policies already include all relevant patientinformation. As part of the Health Plan Interface, a Health Plan MedicalManagement Reviewer Dashboard is provided as a home page to trackauthorization requests.

The RX Specialty Hub system also improves a specialty pharmacy workflowand lessens the time associated with each prior authorization request.Specialty pharmacies are provided with qualified referrals that alreadymeet a health plan's clinical policies. Little additional work is neededto determine if a patient is eligible for therapy and what therapyrequirements have been approved. To track referrals and manage workflow,a Specialty Pharmacy Dashboard is provided for specialty pharmaciesusing the system.

MD Interface (60)

The MD Interface 60 is used by the healthcare provider (physician,nurse, or practice extender) to process a medically-coded drugauthorization requests using RX Specialty Hub's Real Time DecisionInterface 44′. Access to a web-based application is the preferred methodof operation for the RX Specialty HUB system, and it will also beappreciated that a request can be called into RX Specialty Hub andprocessed by a RX Specialty Hub specialist or customer servicerepresentative. Since most of the information is already availablethrough the knowledge base, it will also be appreciated that anautomated telephony system could also be used with verbal menu prompts,a secured smart-phone application, or secured text prompts which may beused in combination with a smart-phone application. For medically codeddrugs, the MD Interface allows for real-time connectivity to the HealthPlan's eligibility files and clinical policies. Once connected,transactions are conducted electronically to reduce turn-around time.

MD Dashboard (52 a)

After a physician enters RX Specialty Hub via secure authentication, asummary of all previous prior authorization requests is shown as part ofthe MD Dashboard 52 a. This dashboard is part of the Real Time DecisionInterface and contains a real time summary of data entered with a uniqueID used for the authorization requests processed within system. Thisdashboard serves as a home page or starting point for healthcareproviders using the tool. The dashboard shows a summary of alltransactions (approved and pended prior authorization requests) enteredby that healthcare provider on the system, tracks authorizationrequests, and identifies additional tasks for completion.

Real Time Decision Interface (44′)

The RX Specialty HUB system can process multiple transactionssimultaneously. For example, it can be expected that the system willhave a transaction rate in the range of between 1 and 4 transactions persecond (TPS) arriving via Provider Web-Direct screens. Each request istransformed into a database query to be validated against the two (2)eligibility data sets from the health plan. The output of the Real TimeDecision Interface will have one of the two optional results listedbelow.

-   -   1. APPROVED    -   2. PENDED—Pending Medical Management Review

Patient Eligibility Check results in APPROVE/PENDED where pendednotifications are presented back to the healthcare provider in the formof their preference, via e-mail or notification via the same webinterface used to submit the request. Requests are tracked in the MDDashboard.

If the patient eligibility is APPROVED, the specific specialty druginformation is cross-referenced regarding the complete form submittedand the RX Specialty Hub system assigns a specific unique authorizationnumber or other authorization code to the transaction. Approvals resultin a Specialty Pharmacy Referral Form sent to the chosen specialtypharmacy. Pended or not-approved requests are sent to the health plan'smedical management staff for further analysis and review. Healthcareproviders are notified that their request is “Pending Medical ManagementReview.” Any decisions or actions based on the health plan's assessmentare managed using the system between the health plan, healthcareprovider, and pharmacy. Unless a new form is submitted, the process isclosed. All requests are tracked and reviewable by the healthcareprovider in the MD Dashboard.

Adaptive Intake Form (14)

As part of an authorization request, an adaptive intake form 14 isgenerated based on patient specific metrics (patient identifiableinformation—PII) 32, drug specific criteria, and each health plan'sclinical policies Ultimately, the inputs are used to determine ifpatients are within a health plan's clinical policies associated withthe criteria listed in the table below.

Health Plan Clinical Policy Criteria

-   -   Is the patient eligible (do they have insurance coverage)?    -   Does the patient's diagnosis meet the health plan's clinical        policy criteria?    -   Do the patient's clinical metrics and will the drug be        administered in a site of care 30″ that meets the health plan's        clinical policies?    -   Does the drug dispensing choice meet a health plan's clinical        policies?

Because the intake form is adaptive based on patient specific metrics(i.e. diagnosis) and drug specific criteria (i.e. drug dose, duration,frequency of administration, and site of administration) only inputsthat are required are prompted for users to enter. By minimizing userinputs, this tool creates both administrative efficiencies and morerobust data collection to determine if a patient meets a health plan'sclinical policies.

Since the RX Specialty Hub system is interactive, it permits theautomatic completion of a number of fields using feeds from the healthplan's database and the patient's EMR which may be contained in oraccessed by the healthcare providers system or the health plan'sdatabase (or some third party database that stores EMRs), therebyreducing data input time and minimizing the potential for theintroduction of typographical and other data input errors. Examples ofautomatic completed field include patient height, weight, diagnosis, labresults, previously used medications, quality of life scores, diagnostictest results, and genetic testing results. Menu drop downs and radioboxes are also used to improve accuracy of information and furtherreduce the input time.

Using the knowledge-base described above, the processor of the inventivesystem highlights or otherwise flags inputs that fall outside of ahealth plan's clinical policies ahead of transmission. In particular,the processor evaluates the medically-coded drug orders relative to thehealth plan's medical benefit policies, as well as the eligibilitystatus and the patient's medical benefit coverage with their healthinsurer. This allows a healthcare provider to modify inputs that are inaccordance with a plan's clinical policies for medication use, or submitas-is because of unique patient needs.

Data Feeds Interface (42)

The Data Feeds Interface is a data processing interface which istransparent to end users. It is integrated with the database platform inthe RX Specialty HUB system. As a stand-alone system, apart from varioushealth plan systems, a patient's health plan eligibility data isprovided to RX Specialty HUB on a periodic basis, preferably daily 42′.Drug specific, health plan-specific clinical policies are also providedperiodically, preferably weekly or monthly 42″. The RX Specialty Hubsystem may also connect with a healthcare provider's EMR software orother clinical data vendors for data feeds 42′″. Additionally, asindicated above, claims paid by the health plan are also electronicallysubmitted to RX Specialty Hub in the HCFA 1500 data set 42″″. Data isintegrated into RX Specialty HUB's SQL database for data processing. Theclinical rules supplied by the plan may be updated incrementallydepending on frequency and volume of changes. It will be appreciatedthat the RX Specialty HUB system could also be implemented within ahealth plan's system rather than as a stand-alone system.

Eligibility Decision (355)

The “Eligibility Approval Interface” is database query check used toprocess the request and is another transparent interface to the users ofthe RX Specialty HUB system. This interface uses a logic engine 44′,such as branching logic, to determine patient eligibility.

As part of the adaptive intake form, a healthcare provider is promptedto select the patient's health plan and drug requested from drop downmenus. The healthcare provider is then prompted to enter the patientname and birth date. Using these initial inputs and the Health PlanEligibility Data Feed, the Real Time Decision Interface determines if apatient is eligible for a prior authorization request using the system.If the patient is eligible, the adaptive intake form uses the inputs togenerate the rules based intake form specific to patient, drug, andhealth plan clinical policies. If the patient is not eligible tocontinue, the healthcare/medical service provider is notified and atime/date stamp is applied to the transaction and stored as part of theMD Dashboard.

Pending Medical Management Decision (360)

Once a healthcare provider has completed entering all information needas part of the Real Time Decision Interface, one of two possibledecisions will be made and a request will have a “Pending for MedicalManagement Review Decision” 360 or the request will have a “PriorAuthorization Approval Decision”. A “Pending Medical Management ReviewDecision” triggers a notification that is returned immediately to therequesting healthcare provider and displayed on the MD dashboard duringthe session. This notification specifically states that the request is“Pending Medical Management Review.” All patient requests (approved andpending) per healthcare provider are listed on a healthcare provider “MDDashboard” report. The MD Dashboard report shows a summary of eachrequest and request approval status (Approved or Pending MedicalManagement Review).

The other pended-request notification is sent to the health plan'smedical management staff and stored in the “Health Plan MedicalManagement Reviewer Dashboard”. Medical Management reviewers arenotified preferably via as part of a direct Health Plan Interface login. Notifications to the health plan may also be sent via e-mail orfacsimile.

Health Plan Medical Management Reviewer Dashboard (52 b)

After the Real Time Decision Interface determines if a priorauthorization request is outside of a health plan's clinical policies, acopy of the inputs are docketed into the “Health Plan Medical ManagementReviewer Dashboard” 52 b. Medical management reviewers from each healthplan log into their dedicated dashboard via secure authentication andare able to view all pended requests as well as view their health plan'sclinical policies. They are then able to determine if a request shouldbe approved or denied. Using checkboxes, a reviewer can provide adisposition for each request, i.e., “approve” or “deny” the request.

If a request is approved, a referral form is generated and sentelectronically or via fax to the specialty pharmacy selected as part ofthe intake form generation by the healthcare provider. The healthcareprovider is notified via email and as part of the MD Dashboard that arequest has been approved. The specialty pharmacy then calls thehealthcare provider to create a verbal prescription and the medicallycoded drug is dispensed per instructions.

If a request is denied, a notification is generated via email and via MDDashboard to the healthcare provider. The process ends at this point.

Health Plan Medical Management Reviewer Interface (84)

The Health Plan Medical Management Reviewer Interface 84 is used by themedical management reviewer to access the health plan's specificrestricted area. As described above with reference to the MD Interface,secure access to the system is the preferred method of operation for theRX Specialty HUB system. Upon entry into the Health Plan MedicalManagement Review Interface, the reviewer has access to view ahealthcare provider's adaptive intake form and determining whether toapprove or deny pended requests. All requests and decisions are storedin the Health Plan Medical Management Reviewer Dashboard. Once adecision is made, the healthcare provider is notified of the decisionvia email and in the MD Dashboard. If the request is approved, theadaptive intake form inputs are used to generate a referral form whichis sent to the specialty pharmacy previously identified by thehealthcare provider. If the request is denied, the healthcare provideris notified via email and in the MD Dashboard.

Prior Authorization Approval Decision (18′)

The “Prior Authorization Approval Decision” 18′ is a decision made usingthe knowledge base of the Real Time Decision Interface. Once a requestis approved the healthcare provider is notified and a uniqueauthorization code or other transaction-specific ID is assigned to theapproved request. The adaptive intake form is used to generate aSpecialty Pharmacy Referral Form that is sent to the dispensing pharmacyto dispense the drug as prescribed. Information regarding the pharmacywould be collected at the time the initial adaptive intake form wascompleted. Facsimile, e-mail, and the Specialty Pharmacy Dashboard areprimary mechanisms to notify pharmacies of approvals. E-prescribingcapabilities are built also into RX Specialty Hub and use all necessaryprotocol. Therefore, with a pharmacy-specific portion of the RXSpecialty HUB application the prescription delivery can be entirelyautomated by, processed through and maintained within the RX SpecialtyHUB system.

Specialty Pharmacy Dashboard (52 c)

After the Real Time Decision Interface determines that a priorauthorization request is within a health plan's clinical policies, theunique identifier or transaction-specific authorization code is assignedto the request, the Specialty Pharmacy Referral Form is generated, and acopy of the inputs are sent to the “Specialty Pharmacy Dashboard” 52 c.Users from each specialty pharmacy log into their Dashboard viaSpecialty Pharmacy Interface 86 and are able to view all approvedrequests as well as each health plan's clinical policies. They are thenprompted to call the physician, verify the prescription, and dispensethe medically coded drug as prescribed and approved. In the event that aphysician is purchasing the medically-coded medication, the physician isidentified as the specialty pharmacy.

If a request had been previously outside of a health plan's clinicalpolicies and subsequently approved by a health plan medical managementreviewer, an electronic prescription or referral form is generated whenthe health plan reviewer approves the request. The same process asdescribed above is used and a Specialty Pharmacy Referral Form isgenerated and sent electronically or via fax to the specialty pharmacyselected and their Specialty Pharmacy Dashboard. The healthcare provideris notified via email and as part of the MD Dashboard that a request hasbeen approved. The specialty pharmacy then calls the healthcare providerto create a verbal prescription and the medically coded drug isdispensed per instructions.

Once dispensed, the NDC of the medically coded drug and the vial size,strength, and number of vials dispensed is entered into the SpecialtyPharmacy Dashboard by the dispensing Specialty Pharmacy.

Specialty Pharmacy Interface (86)

The Specialty Pharmacy Interface is used by the pharmacy to process amedically-coded drug authorization request that RX Specialty Hub's RealTime Decision Interface has determined to be within a health plan'sclinical policies. As described above with reference to the MDInterface, a web-based application is the preferred method of operationfor the RX Specialty HUB system, and it will be appreciated that arequest can be called into RX Specialty Hub and processed by a RXSpecialty Hub specialist or customer service representative.Accordingly, the communication channel or link is secured by the use ofthe user ID and password requirements for accessing the Real TimeDecision Interface as well as other security protocols that can be usedfor receiving information via telephone. For medically coded drugs, theSpecialty Pharmacy Interface allows for real-time connectivity to thehealthcare provider's inputs of patient and drug specific criteria, aswell as to a health plan's clinical policies. As with the MD Interface,transactions are preferably conducted electronically to reduceturn-around time.

J-Code/NDC Conversion Cross-Walk (44″)

The interfaces for the J-Code/NDC Conversion Cross-Walk 44″ allow themedically-coded drugs, such as those assigned a J-code, to be convertedto NDC. The RX Specialty Hub system uses two files to perform the J-codeto NDC crosswalk. One file is a medical claims paid file which isprovided by the health plan and includes the patient specific uniqueauthorization number or other code that RX Specialty Hub had assignedwhen the medication request had been approved for dispensation. Theother file is a Drug Dispensation file which is provided by thespecialty pharmacy either through a separate report or as one of theinputs collected in the Specialty Pharmacy Dashboard and includes thesame patient specific unique authorization code that RX Specialty Hubhad provided to the specialty pharmacy to link the dispensed medicationwith the particular drug order submitted by the healthcare provider.

The Rx Specialty Hub system reconciles specialty pharmacy and healthplan data feeds to create a J-code to NDC conversion, i.e., reconcilethe medically-coded drugs with the prescription NDC drug codes. Once theNDC is assigned, volumes of medications dispensed per NDC are calculatedby the RX Specialty HUB system. These calculations create measurablerebate opportunities that health plans may have in their contracts withpharmaceutical manufacturers.

The cross-walk process is generally not executed in real time. Instead,it is processed after the medically-coded drugs have been ordered anddispensed and a reasonable period of time is given for a claim to besubmitted to the health plan for reimbursement. Accordingly, thecross-walk processing may occur approximately 30-60 days after themedically-coded drug has been dispensed. The Rx Specialty Hub systemuses a match between the authorization code from the specialty pharmacyand the authorization code from original request from the healthcareprovider. The health plan may be required to submit HCFA 1500 data feedsfor the in the cross-walk.

Patient Exchange (54)

RX Specialty Hub allows physicians 30 to provide patients 32 with andprint education materials, websites, and links to advocacy groups 56once a patient's prior authorization request has been approved. Patientmaterials are provided to improve education and understanding ofdisease, medication prescribed, and medication administration. Byproviding education materials, patients are more compliant to theirmedication. Safety for patients is also improved by providing additionalinformation such as a Food and Drug Administration (FDA) approved drugmonograph. Drug monographs represent published standards for the use ofone or more substances.

In addition to providing medication and disease related materials forpatients, compliance tools such as an email reminder 56′ and/or calendarinvite 56″ reflecting drug administration schedules can be programmedfor patients, and transmitted directly to the patient. Other compliancetools that can be provided as part of the patient exchange include hardcopy schedule of administration, information to advocacy groups, copayassistance foundation information, or additional information dedicatedto help patients maintain compliance to their medications.

Reporting Suite

The RX Specialty HUB permits the creation of specialized reports thathad not been previously available using manual processes. With theautomated and integrated RX Specialty HUB system, its sharing of dataand feedback loops, specialty drug reports can be provided to healthplans, medical offices, pharmaceutical manufacturers, and specialtypharmacies. Reports can readily be formulated and automaticallygenerated based on the particular requirements of these parties, and canbe delivered via secure FTP, secure e-mail or accessed within thesystem's dashboards. The data created and accumulated through the RXSpecialty Hub system would be de-identified at the member level beforeit is made available to pharmaceutical manufacturers as reports from thesystem. Several examples of reportable metrics are listed in the tablebelow.

Type Report Chart Frequency Overview Total # of referrals in Quarter QReferrals by Therapeutic Class yes Q Referrals by Class, by Brand yes QMembers in each Class yes Q Trend: referrals vs. last quarter yes QTrend: within each therapeutic yes Q class Detail Referrals by Geographymap Q Member breakdown by Group yes Q Therapeutic Class: breakdown yes Qby Drug Therapeutic Class: breakdown Q by Member Therapeutic Class:breakdown Q by Physician Therapeutic Class: breakdown yes Q by Site ofCare Therapeutic Class: breakdown Q by Admin Auth Therapeutic Class:breakdown by diagnosis Pharmacy Provider Detail yes Q Op Metrics #Authorized Q # Pending Review by Health Q Plan Reviewer EventualApprovals vs Denials yes Q on Pending Speed to Auth Q Average time inPend Que Q Speed to answer Customer Q Service Calls Financial J-Code toNDC Crosswalk Q/A Therapeutic Class: Market yes Q/A Share of BrandsTherapeutic Class: PMPM cost A Member PMPM Costs by Group A Trend PolicyChanges, Edits Q/A Analysis/ Site of Care Q/A RecommendationManufacturer Contracting Q/A Pharmacy Provider Contracting/ Q/A AuditIntervention Quantify value of prospective hub Q/A

Screen Shots of RX Specialty HUB Application

The RX Specialty HUB web link would be used by the healthcare providersto make online prior authorization requests. The healthcare providerswould log in securely through an access portal screen as displayed inFIG. 4.

The healthcare provider selects the health plan, medically-coded drug ordisease state, and treatment required for the patient using drop downmenus as shown in FIG. 5. The healthcare provider information would belisted in the Prescriber Information tab on the primary RX Specialty HUBinterface screen as shown in FIG. 6A. The patient would be identified onthe Member Information tab on the RX Specialty HUB interface screen, andtheir information would then be automatically uploaded to the screen asshown in FIG. 6B so that the healthcare provider could confirm that thecorrect patient is listed. When the healthcare provider selects theValidate Member radio button, the patient information is run through theauthentication and validation evaluations as discussed above for theparticular medically-coded drug that the healthcare provider hadselected in the previous step. The RX Specialty HUB system is able tomake this determination typically within five (5) minutes in mostinstances with most evaluations being performed within one (1) to ten(10) minutes. Information regarding the diagnosis would be collectedusing drop down fields and database queries.

As shown in FIG. 7, drug specific criteria are selected using adrop-down menu of ICD-9 diagnosis codes and the therapy status for thepatient can be selected using radio buttons for initiating therapy orcontinuing therapy. The RX Specialty HUB system already has theinformation on the patient weight and maintains a knowledge-base withother selectable criteria. Accordingly, the drug dosage, therapyduration, and the pharmacy network are entered using menu driven fields.The RX Specialty HUB system also tracks the need by date for themedically-coded drug. An adaptive intake form using branching logic ispreferably used to create specific inputs required to determine therapyapprovability. The healthcare provider selects the Validate Prescriptionbutton, and the RX Specialty HUB Real Time Decision Interfaceautomatically evaluates all of the inputted criteria against clinicalpolicies and guidelines approved by the health plan to determine whetherthe drug authorization is approved or whether it requires further reviewby a health plan's medical management. FIG. 8 shows the Drug andPharmacy Information screen that appears when the drug authorization isapproved. This screen displays the Authentication Code for thetransaction which is the unique authorization code that is assigned tothe authorization approval from the health plan and the order that isplaced with the specialty pharmacy for the medically-coded drugs.

The MD Dashboard uses the information that it collects and tracks toprovide reports for the healthcare provider. For example, the report inFIG. 9 shows a summary and current status of the requestedauthorizations that a healthcare provider (“prescriber”) has processedthrough the RX Specialty HUB system.

As discussed above and shown in FIG. 10, the RX Specialty HUB system cangenerate an email confirmation for each approved authorization that issent to the healthcare provider and the specialty pharmacy.

The RX Specialty HUB system also gives the health plan's medicalreviewer the ability to view pending authorizations that require furtherreview using the Health Plan Medical Management Reviewer Interface. Asshown by FIG. 11, the medical reviewer can filter the authorizationsbased on various selection criteria and track tasks as part the HealthPlan Medical Management Reviewer Dashboard.

The health plan's medical reviewer can view pending authorizations thatrequire further assessment, and can approve or deny dispensation of thedrug. If the reviewer approves dispensation of the medically-coded drug,a notification is provided to the healthcare provider as part of theirMD Dashboard, and a referral form is generated and sent to thehealthcare provider's previously chosen specialty pharmacy and to theSpecialty Pharmacy Dashboard. Upon receipt of the referral form, thespecialty pharmacies call the healthcare provider to verify the dosageand administration of the medication. This process creates a verbalprescription used by the specialty pharmacy to fill the medication. Atthis point, the process is closed until a “continuation” of therapyrequest is created within the system.

From the preceding description of the RX Specialty HUB system, it isevident that the present invention has a number of features andfunctionality which are not found in current systems and processes,including the unique aspects of the invention listed in the table below.

Unique Features & Functions of Invention

-   -   Real Time prior authorization processing specific to health plan        policies, prescriber needs, and patient needs    -   Tiered formulary management of Specialty/Biological Drugs and        rebate generation opportunities    -   Rebate capture by creating a J code to NDC crosswalk and        conversion (linking quantity of dispensed drug to NDC number and        quantity)    -   Real time intervention to direct patients to a specific and        appropriate site of care (home infusion, hospital infusion,        physician office infusion)    -   Drug specific deterministic criteria based ICD-9 diagnosis,        initiation or continuation of therapy, and on industry/evidence        based guidelines    -   Clinical Parameters (lab values and other clinical metrics),        Site of Care for Medication Administration, and Medication        Dispensing information prospectively captured at one time    -   Care Alerts reminding prescribers of precautions needed with        usage or administration of medication    -   Drug and disease information, as well as Compliance Reminders        transmitted directly to the patient    -   Monitoring capacity to improve appropriate duration of therapy        and discontinuation of ineffective medication (includes lab        value monitoring, Quality of Life monitoring, and other efficacy        metrics)    -   E-Prescribing    -   Connectivity and automated transactions to find relevant        clinical metrics in a patient's EMR    -   NDC assigned to all medications dispensed as part of a medical        benefit    -   Drug specific and market share dispensing analytics    -   Complete patient information provided for Medical Management        Review only when parameters are outside of clinical policies    -   Email notification of reminders to physicians and Medical        Management Reviewers    -   Consistent referral forms generated for approved request and        provided in real time to Specialty Pharmacies for drug        fulfillment. Provided via fax, email, or web-based transactions.    -   Reduced non-approved experimental use of medications

Although some current systems provide utilization management programswith web-based physician authorization programs, they fail to integratethe front end medical office authorization with orders formedically-coded drugs. Accordingly, there is no present system which canautomate the process for obtaining approval authorization onmedically-coded drugs and track the information on the dispensedmedically-coded drugs for rebate collection, nor can any current systemprovide the healthcare provider with the selection criteria forclinical, site of care, and dispensing inputs using a knowledge-basesystem. Finally, it will be appreciated that the current systems arestill primarily based on the old manual processes rather than theinteractive, real-time system of the present invention. Therefore, thecurrent systems typically require days to complete the authorizationapproval process whereas the RX Specialty HUB system completes theend-to-end authorization approval process within minutes.

It will be appreciated that the particular way in which theknowledge-base is integrated with the interactive ordering system withthe feedback system solves the inadequacies of current systems andresults not only in benefits that have not been realized before but areunexpected when considering each of the known systems in an individualmanner or when merely combining the features of these known systemswithout integrating the front end authorization approval with theordering and tracking of the medically-coded drugs that are actuallydispensed for the treatment of patients.

The embodiments were chosen and described to best explain the principlesof the invention and its practical application to persons who areskilled in the art. As various modifications could be made to theexemplary embodiments, as described above with reference to thecorresponding illustrations, without departing from the scope of theinvention, it is intended that all matter contained in the foregoingdescription and shown in the accompanying drawings shall be interpretedas illustrative rather than limiting. Thus, the breadth and scope of thepresent invention should not be limited by any of the above-describedexemplary embodiments, but should be defined only in accordance with thefollowing claims appended hereto and their equivalents.

1. A method for authorizing and dispensing medically-coded drugs,comprising: providing a database of criteria for medically-coded drugsassociated with a plurality of health plans and for patient identifiableinformation associated with said health plans; interactively receivingan input from a user in which a particular patient is identified, amedically-coded drug is selected, a specialty pharmacy is chosen and aprior authorization request is submitted, wherein said user providessaid input on behalf of a healthcare provider; determining a health plancorresponding with said identified patient in said database andevaluating said criteria for said selected medically-coded drug;providing an authorization code to said user corresponding with saidselected medically-coded drug and said identified patient; receiving apharmacy dispensing report from said chosen specialty pharmacy, whereinsaid pharmacy dispensing report is associated with said authorizationcode and provides a pharmacy confirmation that said selectedmedically-coded drug was dispensed to at least one of said healthcareprovider and said identified patient; receiving a medical claims reportfrom said health plan, wherein said medical claims report is associatedwith said authorization code and provides a medical confirmation thatsaid selected medically-coded drug was administered to said identifiedpatient at the approved dosage; and updating said database withutilization data corresponding to said pharmacy dispensing report andsaid medical claims report.
 2. The invention of claim 1, wherein saidcriteria for medically-coded drugs is health plan-specific criteria. 3.The invention of claim 1 further comprising the step of automaticallygenerating a referral form corresponding to said healthcare provider andsaid chosen specialty pharmacy.
 4. The invention of claim 1, whereinsaid user is a medical office staff member with said healthcare providerand wherein said authorization code is provided during a period of timewherein said user is engaged in said interactive session, wherein saidperiod of time is within ten minutes following receiving said input fromsaid user, and wherein said input further comprises a defined therapycriteria corresponding with said identified patient and said selectedmedically-coded drug.
 5. The invention of claim 4 further comprising thesteps of automatically completing a plurality of data fields in aninterface screen with information from said database based on said userinput; receiving periodic data feeds from said health plans, whereinsaid data feeds comprise eligibility data sets with health plan criteriaand patients associated therewith; automatically integrating said healthplan criteria from said periodic data feeds into said criteria in saiddatabase and updating said criteria in said database with said healthplan criteria from said periodic data feeds; evaluating said criteriacorresponding to said health plan of said identified patient and saidselected medically-coded drug for said defined therapy criteria, whereinsaid therapy criteria is at least one of a duration period and a dosagelevel; creating an authentication code as a unique transactionidentifier between said healthcare provider and said identified patientfor said selected medically-coded drug and said therapy criteria;submitting said authorization code to said chosen specialty pharmacy;performing a cross-walk process to reconcile said medically-coded drugwith prescription drug codes; and calculating a volume of medicationfrom said cross-walk.
 6. The invention of claim 5 wherein saidcross-walk is performed after said medically-coded drugs have beenordered and dispensed, said cross-walk processing said pharmacydispensing report and said medical claims report which are matchedaccording to said authorization code.
 7. The invention of claim 1,wherein said receiving step is further comprised of at least one of thesteps selected from the set of steps consisting of: receiving said inputelectronically through a computer network, receiving said inputelectronically through a computer system in combination with anautomated telephony system, receiving said input orally throughtelephony between said healthcare provider user and a centralizeddata-entry service provider, and any combination thereof.
 8. Theinvention of claim 7, wherein said oral receipt step further comprisesthe steps of said centralized data-entry service provider electronicallyentering said orally received input through a computer system andelectronically receiving said input through said computer system.
 9. Theinvention of claim 1, wherein said health plan determination step isfurther comprised of the steps of evaluating an eligibility of saidpatient in said health plan, evaluating a patient's diagnosis relativeto a first set of clinical policies in said health plan, evaluating apatient's clinical values and site of care relative to a second set ofclinical policies in said health plan, evaluating a specialty pharmacyselection relative to a set of dispensing options in said health plan,notifying said healthcare provider of a pending medical managementdecision, and docketing a pended request in a medical managementreviewer dashboard for viewing and entering a disposition.
 10. Theinvention of claim 9, further comprising the step of receiving from saidhealthcare provider user supporting documentation for a justified use ofsaid medically-coded drug with said particular patient outside saidclinical policies in said health plan according to said pending medicalmanagement decision.
 11. The invention of claim 1, wherein saidauthorization code further corresponds with said chosen pharmacy and apreferred site of care and wherein said authorization code uniquelyidentifies and links said dispensed medically-coded drug with a drugorder submitted by said healthcare provider.
 12. The invention of claim1, wherein said pharmacy confirmation further comprises a dosing detailat the NDC level and further comprising communicating patientinformation and educational materials to said healthcare providerthrough a patient exchange.
 13. The invention of claim 1 furthercomprising the steps of accumulating said utilization data with aplurality of utilization data from a plurality of pharmacy dispensingreports and a plurality of medical claims reports associated with aplurality of respective authorization codes; and preparing a utilizationreport from said accumulated data.
 14. The invention of claim 1 furthercomprising the steps of: performing a cross-walk process in which saidpharmacy dispensing report and said corresponding said medical claimsreport are matched according to said authorization code and saidmedically-coded drug is reconciled with said prescription drug codes;accumulating said utilization data with a plurality of utilization datafrom a plurality of pharmacy dispensing reports and a plurality ofmedical claims reports associated with a plurality of respectiveauthorization codes; preparing a utilization report from saidaccumulated data; and reconciling rebate amounts according to saidutilization report.
 15. A method for authorizing and dispensingmedically-coded drugs, comprising: authenticating user rights to accessa web-enabled login page as an authorized healthcare provider; accessinga database through a healthcare provider interface page, wherein saiddatabase comprises criteria for a plurality of medically-coded drugsassociated with a plurality of health plans and patient identifiableinformation associated with said health plans, said database furthercomprising information on a plurality of specialty pharmacies withcapabilities to dispense a set of said medically-coded drugs, andwherein said healthcare provider interface page comprises a plurality ofdata fields; entering input data into a plurality of data fields on saidhealthcare provider interface page, wherein said input data comprisesinformation identifying a patient, a selection of a medically-coded drugfrom a listing of said medically-coded drugs and a corresponding therapycriteria, and a choice of a specialty pharmacy from a listing of saidspecialty pharmacies; receiving additional information on saidhealthcare provider interface page that is automatically populated intosaid data fields from said database for said identified patient;entering an authorization request on said healthcare provider interface;and receiving an authorization code, wherein said authorization codecomprises an authentication code as a unique transaction identifierbetween said authorized healthcare provider and said identified patientfor said selected medically-coded drug and said corresponding therapycriteria.
 16. The invention of claim 26, wherein said authorization codeis received within ten minutes after entering said authorizationrequest.
 17. The invention of claim 15, wherein said authorization codeis received after entering said authorization request and while saidauthorized healthcare provider has authenticated user rights and isaccessing said healthcare provider interface page.
 18. The invention ofclaim 15, wherein said therapy criteria is at least one of a durationperiod and a dosage level.
 19. The invention of claim 15, wherein saidautomatically populated additional information is selected from thegroup of information consisting of: patient information, health planinformation and therapy options.
 20. The invention of claim 15 furthercomprising the steps of receiving said selected medically-coded drugfrom said chosen specialty pharmacy; administering said selectedmedically-coded drug to said identified patient; and submitting amedical claims report to said database, wherein said medical claimsreport comprises said authorization code with a medical confirmationthat said selected medically-coded drug was administered to saididentified patient.
 21. The invention of claim 20, further comprisingthe steps: accumulating said utilization data with a plurality ofutilization data from a plurality of pharmacy dispensing reports and aplurality of medical claims reports associated with a plurality ofrespective authorization codes; and reconciling rebate amounts.
 22. Theinvention of claim 15 further comprising the steps of repeating thesteps of data entry, administering said medically-coded drug andsubmitting said medical claims report for a plurality of medically-codeddrugs and corresponding patients, and after repeating the steps,receiving a report summarizing volumes of said medically-coded drugsadministered to said patients, wherein said report contains a cross-walkkey correlating said medically-coded drugs with correspondingprescription drug codes.
 23. A method for authorizing and dispensingmedically-coded drugs, comprising: providing a database of criteria formedically-coded drugs associated with a plurality of health plans andfor patient identifiable information associated with said health plans;receiving periodic data feeds from said health plans, wherein said datafeeds comprise eligibility data sets with health plan criteria andpatients associated therewith; automatically integrating said healthplan criteria from said periodic data feeds into said criteria in saiddatabase and updating said criteria in said database with said healthplan criteria from said periodic data feeds; receiving a login requestfrom a healthcare provider; verifying said login request is from ahealthcare provider with rights to access at least certainmedically-coded drug data and health plan data in said database;displaying an interface screen having a plurality of data fields inwhich said healthcare provider can provide patient identifiableinformation and having lists of said medically-coded drugs;interactively receiving an input from said healthcare provider, whereinsaid input comprises information identifying a patient and a selectingmedically-coded drug; automatically completing a plurality of said datafields with information from said database based on said healthcareprovider input; receiving a prior authorization request corresponding tosaid identified patient and said selected medically-coded drug for adefined therapy criteria, wherein said therapy criteria is at least oneof a duration period and a dosage level; verifying said identifiedpatient satisfies said criteria in said database; assigning anauthorization code to said prior authorization request, wherein saidauthorization code comprises an authentication code as a uniquetransaction identifier between said healthcare provider and saididentified patient for said selected medically-coded drug and saiddefined therapy criteria; transmitting electronically to said patient aDrug Monograph, relevant messaging about a prescribed therapy, andcalendar reminders about medication adherence; receiving a pharmacydispensing report associated with said authorization code, wherein saiddispensing report comprises a pharmacy confirmation from a specialtypharmacy indicating that said selected medically-coded drug associatedwith said authorization code was dispensed to said healthcare provider;receiving a medical claims report associated with said authorizationcode, wherein said claims report comprises a medical confirmation fromsaid healthcare provider indicating that said selected medically-codeddrug associated with said authorization code was administered to saididentified patient; automatically updating said database withutilization data corresponding to said pharmacy dispensing report andsaid medical claims report; accumulating said utilization data with aplurality of utilization data from a plurality of pharmacy dispensingreports and a plurality of medical claims reports associated with aplurality of respective authorization codes; preparing a utilizationreport from said accumulated data; and reconciling rebate amounts. 24.The invention of claim 23, further comprising the steps of: identifyingnon-selectable options that are not within a clinical policy; whereinsaid clinical policy can be based on at least one of said identifiedpatient's policy with said health plan and said health plan's overallclinical policies; submitting said authorization code to a specialtypharmacy with corresponding information on said identified patient andsaid healthcare provider; performing a cross-walk process on saidpharmacy dispensing report and said corresponding said medical claimsreport having said authorization code to reconcile said medically-codeddrug with prescription drug codes; and calculating volumes ofmedications from said cross-walk.
 25. A method for authorizing anddispensing medically-coded drugs, comprising: providing a database ofcriteria for medically-coded drugs associated with eligibility data fora health plan and for patient identifiable information associated withsaid eligibility data; receiving a login request from a user, whereinsaid user has an authorization from a healthcare provider; displaying aninterface screen having a plurality of data fields in which said usercan provide patient identifiable information and having lists of saidmedically-coded drugs; interactively receiving an input from said user,said input comprising an identification of a patient, a selection of amedically-coded drug, a choice of a specialty pharmacy, and a requestfor a prior authorization approval; evaluating said criteria for saidselected medically-coded drug and said eligibility data for saididentified patient; providing an authorization code to said user forsaid selected medically-coded drug and said identified patient;transmitting electronically to said patient a Drug Monograph, relevantmessaging about a prescribed therapy, and calendar reminders aboutmedication adherence; receiving a pharmacy dispensing report from saidchosen specialty pharmacy, wherein said pharmacy dispensing report isassociated with said authorization code and provides a pharmacyconfirmation that said selected medically-coded drug was dispensed tosaid healthcare provider; receiving a medical claims report from saidhealthcare provider, wherein said medical claims report is associatedwith said authorization code and provides a medical confirmation thatsaid selected medically-coded drug was administered to said identifiedpatient; and updating said database with utilization data correspondingto said pharmacy dispensing report and said medical claims report.